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Shedding Light on the Risks
& Benefits of Medications FDA SIDE EFFECTS UPDATE: Abilify Pregnancy Risk And More
Safety updates sourced directly from the FDA's Drug Safety Database, presented in clear and accessible language
March 17, 2025
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Welcome to the FDA Side Effects Update. This series is designed to keep you informed about the latest safety advisories and newly documented side effects of your medications. In this installment, we’re highlighting safety updates concerning Abilify, Adcertis, Enhertu, Dayvigo, and Osphena.
How to Read This Report
This report is prepared using the most recent information posted in the SrLC database. It highlights recent safety labeling changes. It includes only newly reported side effects and safety information; additional side effects and warnings will appear on the drug label. Not all recent changes to the SrLC database or the label may be listed here. For all changes and the complete list of warnings and side effects, please click on the drug label link.
Each of the items (approval and update dates, drug names, etc.) contained in this report are obtained from the SrLC. The side effects and medication descriptions are simplified and made clearer, if needed. Sometimes, additional sources, like a medical dictionary, may be used to translate technical medical phrases. Other sources (company news, FDA press releases, etc.) may be used to learn about some label changes.
Abilify, Abilify Asimtufii, Abilify Maintena, Abilify Mycite (active ingredient: aripiprazole) tablets; Aristada (active ingredient: aripiprazole lauroxil) tablets
Initial FDA Approval: 2002
Side Effect Update Date: January 22, 2025
Medication Description: Aripiprazole is an antipsychotic drug used to treat various mental health conditions, including schizophrenia, bipolar disorder, irritability associated with autistic disorder and depression. It is also approved to treat Tourette’s disorder, a nervous system condition.
Updated Side Effects/Safety Information: Clinical trials results relating to Abilify orally disintegrating tablet, oral solution, and intramuscular injections were removed, as the name-brand formulations have been discontinued. However, those formulations are still available as generic versions. Lactation-related clinical trials results were added, suggesting that exposure during pregnancy and/or the postpartum period can lead to decreases in milk supply or no milk supply in the post-partum period. The breastfed infant should be monitored for dehydration and lack of appropriate weight gain. There is a patient exposure registry that monitors pregnancy outcomes in women exposed to Abilify during pregnancy. More pregnancy risks are listed on the drug label.
Cases of fecal incontinence have been reported for this drug and the new side effect risk was added to the list of postmarketing experiences. The FDA recently required that this newly recognized adverse effect be added to many antipsychotic drugs.
FDA Safety Announcement: Abilify FDA Safety Label Change and Revised Drug Label
Adcetris (active ingredient: brentuximab vedotin) for intravenous infusion
Initial FDA Approval: 2011
Side Effect Update Date: February 11, 2025
Medication Description: Treats adults and children with various forms of lymphoma, a type of blood cancer.
Updated Side Effects/Safety Information: New clinical trials results were added to the label supporting its recent approval to treat Relapsed or Refractory Large B-Cell Lymphoma in conjunction with other drugs. Also, new clinical trials data about the risk of peripheral neuropathy was added to the Warnings and Precautions section. Peripheral neuropathy is a nerve condition characterized by numbness, tingling, or burning in extremities like the hands, fingers, and feet. Peripheral neuropathy is a common adverse reaction for this drug, and a table provides dosage modifications to be made until the condition improves. Clinical trial data for geriatric use were also added.
FDA Safety Announcement: Adcetris FDA Safety Label Change and Revised Drug Label
Dayvigo (active ingredient: lemborexant) tablets
Initial FDA Approval: 2019
Side Effect Update Date: February 19, 2025
Medication Description: Treats insomnia in adults.
Updated Side Effects/Safety Information: Updated information for its registry for women who are exposed to Dayvigo during pregnancy or who become pregnant while taking Dayvigo, including a new phone number and website, The National Pregnancy Registry for Psychiatric Medications.
FDA Safety Announcement: FDA Dayvigo Safety Label Change and Revised Drug Label
Enhertu (active ingredient: trastuzumab deruxtecan) intravenous infusion
Initial FDA Approval: 2019
Side Effect Update Date: January 27, 2025
Medication Description: Treats breast cancer.
Updated Side Effects/Safety Information: The label was updated to support its expanded approval for treating HER2-low or ultralow (earlier stages) of breast cancer, as determined by an FDA-approved antibody test that screens patients likely to respond to Enhertu. The label includes clinical trials results indicating that there was no difference in efficacy in patients age 65 and older treated for HER2-low or ultralow breast cancer compared to younger patients treated for the same types of cancer. However, there was a higher incidence of Grade 3-4 (more severe) adverse reactions observed in those older patients being treated for HER2-low or ultralow compared to younger patients. Grade 3 is considered severe, and Grade 4 is life-threatening, according to the NLM grading scale for adverse events.
FDA Safety Announcement: Enhertu FDA Safety Label Change and Revised Drug Label
FDA Press Release on Enhertu expanded approval
Osphena (active ingredient: ospemifene) tablets
Initial FDA Approval: 2013
Side Effect Update Date: February 7, 2025
Medication Description: Treats vaginal atrophy and dryness due to menopause.
Updated Side Effects/Safety Information: The label was changed to add results from the Women’s Health Initiative (WHI) clinical trials, which show an increased risk of breast cancer for estrogen plus progestin therapy and a smaller increased risk for estrogen-only therapy after several years of use. A warning was added that women with a history of breast cancer or have suspected breast cancer should not use ospemifene. This drug has an association with endometrial cancer, and has a boxed warning about this risk.
Essential Extras: Osphena is different from hormones or estrogen replacement therapy (like estradiol pills or cream) because it works by acting like estrogen in some parts of the body. It belongs to a class of drugs called selective estrogen receptor modulators (SERM)
FDA Safety Announcement: Osphena FDA Safety Label Update and Revised Drug Label
Want to Share Your Story?
If you’ve experienced side effects or medication issues related to this topic, we want to hear from you.
Submit Your Story- DRUG SAFETY-RELATED LABELING CHANGES (SRLC)
- DRUGS@FDA: FDA APPROVED DRUGS
- ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS
- NATIONAL LIBRARY OF MEDICINE’S DAILYMED DRUG LABEL DATABASE
- MERRIAM-WEBSTER MEDICAL DICTIONARY
- Peripheral neuropathy. (n.d.). National Institute of Neurological Disorders and Stroke
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Article HTML
<!-- wp:paragraph -->
<p>Welcome to the FDA Side Effects Update. This series is designed to keep you informed about the latest safety advisories and newly documented side effects of your medications. In this installment, we’re highlighting safety updates concerning Abilify, Adcertis, Enhertu, Dayvigo, and Osphena.</p>
<!-- /wp:paragraph --><!-- wp:heading -->
<h2 class="wp-block-heading">How to Read This Report</h2>
<!-- /wp:heading --><!-- wp:paragraph -->
<p>This report is prepared using the most recent information posted in the <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm" target="_blank" rel="noreferrer noopener">SrLC database</a>. It highlights recent safety labeling changes. It includes only newly reported side effects and safety information; additional side effects and warnings will appear on the drug label. Not all recent changes to the SrLC database or the label may be listed here. For all changes and the complete list of warnings and side effects, please click on the drug label link.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>Each of the items (approval and update dates, drug names, etc.) contained in this report are obtained from the SrLC. The side effects and medication descriptions are simplified and made clearer, if needed. Sometimes, additional sources, like a medical dictionary, may be used to translate technical medical phrases. Other sources (company news, FDA press releases, etc.) may be used to learn about some label changes.</p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Abilify, Abilify Asimtufii, Abilify Maintena, Abilify Mycite (active ingredient: aripiprazole) tablets; Aristada (active ingredient: aripiprazole lauroxil) tablets</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Initial FDA Approval:</strong> 2002</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Side Effect Update Date:</strong> January 22, 2025</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Aripiprazole is an antipsychotic drug used to treat various mental health conditions, including schizophrenia, bipolar disorder, irritability associated with autistic disorder and depression. It is also approved to treat Tourette’s disorder, a nervous system condition.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: Clinical trials results relating to Abilify orally disintegrating tablet, oral solution, and intramuscular injections were removed, as the name-brand formulations have been discontinued. However, those formulations are still available as generic versions. Lactation-related clinical trials results were added, suggesting that exposure during pregnancy and/or the postpartum period can lead to decreases in milk supply or no milk supply in the post-partum period. The breastfed infant should be monitored for dehydration and lack of appropriate weight gain. There is a<a href="https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/" target="_blank" rel="noreferrer noopener"> patient exposure registry</a> that monitors pregnancy outcomes in women exposed to Abilify during pregnancy. More pregnancy risks are listed on the drug label.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>Cases of fecal incontinence have been reported for this drug and the new side effect risk was added to the list of postmarketing experiences. The FDA recently required that this newly recognized adverse effect be added to many antipsychotic drugs.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>FDA Safety Announcement: </strong><a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=38" target="_blank" rel="noreferrer noopener">Abilify FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021436s046s050lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Drug Label</a></p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Adcetris (active ingredient: brentuximab vedotin) for intravenous infusion</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2011</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Side Effect Update Date:</strong> February 11, 2025</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats adults and children with various forms of lymphoma, a type of blood cancer.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: New clinical trials results were added to the label supporting its recent approval to treat Relapsed or Refractory Large B-Cell Lymphoma in conjunction with other drugs. Also, new clinical trials data about the risk of peripheral neuropathy was added to the Warnings and Precautions section. <a href="https://www.ninds.nih.gov/health-information/disorders/peripheral-neuropathy" target="_blank" rel="noreferrer noopener">Peripheral neuropathy</a> is a nerve condition characterized by numbness, tingling, or burning in extremities like the hands, fingers, and feet. Peripheral neuropathy is a common adverse reaction for this drug, and a table provides dosage modifications to be made until the condition improves. Clinical trial data for geriatric use were also added.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=81" target="_blank" rel="noreferrer noopener">Adcetris FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125388Orig1s108lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Drug Label</a></p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Dayvigo (active ingredient: lemborexant) tablets</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2019</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Side Effect Update Date:</strong> February 19, 2025</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats insomnia in adults.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: Updated information for its registry for women who are exposed to Dayvigo during pregnancy or who become pregnant while taking Dayvigo, including a new phone number and website, <a href="https://womensmentalhealth.org/research/pregnancyregistry/" target="_blank" rel="noreferrer noopener">The National Pregnancy Registry for Psychiatric Medications</a>.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>:<a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2317" target="_blank" rel="noreferrer noopener"> FDA Dayvigo Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212028s011lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Drug Label</a></p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Enhertu (active ingredient: trastuzumab deruxtecan) intravenous infusion</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2019</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Side Effect Update Date:</strong> January 27, 2025</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats breast cancer.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: The label was updated to support its expanded approval for treating HER2-low or ultralow (earlier stages) of breast cancer, as determined by an FDA-approved antibody test that screens patients likely to respond to Enhertu. The label includes clinical trials results indicating that there was no difference in efficacy in patients age 65 and older treated for HER2-low or ultralow breast cancer compared to younger patients treated for the same types of cancer. However, there was a higher incidence of Grade 3-4 (more severe) adverse reactions observed in those older patients being treated for HER2-low or ultralow compared to younger patients. Grade 3 is considered severe, and Grade 4 is life-threatening, according to the <a href="https://cde.nlm.nih.gov/deView?tinyId=Su71nJ0K1WH" target="_blank" rel="noreferrer noopener">NLM grading scale</a> for adverse events.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>:<a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2390" target="_blank" rel="noreferrer noopener"> Enhertu FDA Safety Label Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761139s032s035lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised Drug Label</a></p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2" target="_blank" rel="noreferrer noopener">FDA Press Release</a> on Enhertu expanded approval</p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Osphena (active ingredient: ospemifene) tablets</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2013</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: February 7, 2025</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats vaginal atrophy and dryness due to menopause.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: The label was changed to add results from the Women’s Health Initiative (WHI) clinical trials, which show an increased risk of breast cancer for estrogen plus progestin therapy and a smaller increased risk for estrogen-only therapy after several years of use. A warning was added that women with a history of breast cancer or have suspected breast cancer should not use ospemifene. This drug has an association with endometrial cancer, and has a boxed warning about this risk.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>Essential Extras</strong>: Osphena is different from hormones or estrogen replacement therapy (like estradiol pills or cream) because it works by acting like estrogen in some parts of the body. It belongs to a class of drugs called <a href="https://medlineplus.gov/druginfo/meds/a613039.html" target="_blank" rel="noreferrer noopener">selective estrogen receptor modulators</a> (SERM)</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p><strong>FDA Safety Announcement:</strong> <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1735" target="_blank" rel="noreferrer noopener">Osphena FDA Safety Label Update</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203505s018lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised Drug Label</a></p>
<!-- /wp:paragraph -->